{"id":6878,"date":"2020-02-07T13:14:07","date_gmt":"2020-02-07T13:14:07","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=6878"},"modified":"2021-04-06T12:36:40","modified_gmt":"2021-04-06T12:36:40","slug":"writing-a-clinical-evaluation-report-5-quick-tips","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/es\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/","title":{"rendered":"Escribir un informe de evaluaci\u00f3n cl\u00ednica: 5 consejos r\u00e1pidos"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Tabla de contenidos<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f6248680d80\" aria-label=\"Tabla de contenidos\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f6248680d80\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/es\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/#1_Define_a_CER_protocol_and_strategy\" title=\"1. Definir un protocolo y una estrategia de RCE\">1. Definir un protocolo y una estrategia de RCE<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/es\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/#2_Demonstrate_equivalence\" title=\"2. Demostrar la equivalencia\">2. Demostrar la equivalencia<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/es\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/#3_Evaluate_literature_review_data\" title=\"3. Evaluar los datos de la revisi\u00f3n de la literatura\">3. Evaluar los datos de la revisi\u00f3n de la literatura<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/es\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/#4_Determine_requirement_for_clinical_investigation\" title=\"4. Determinar los requisitos para la investigaci\u00f3n cl\u00ednica\">4. Determinar los requisitos para la investigaci\u00f3n cl\u00ednica<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/es\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/#5_Monitor_post-market_activities\" title=\"5. Supervisar las actividades posteriores a la comercializaci\u00f3n\">5. Supervisar las actividades posteriores a la comercializaci\u00f3n<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Sophie Laurenson, <a href=\"https:\/\/www.kolabtree.com\/blog\/es\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">salud<\/a> &amp; technology innovator\u00a0on Kolabtree, shares 5 tips for writing a clinical evaluation report and defining a CER strategy.<\/em><\/p>\n<p>El MDR de la UE ha tenido un impacto significativo en la forma en que se regulan los dispositivos m\u00e9dicos en Europa. Como parte del cumplimiento de la normativa, los fabricantes de productos sanitarios deben crear y mantener un informe de evaluaci\u00f3n cl\u00ednica (CER), un documento esencial para el marcado CE. A continuaci\u00f3n se ofrecen consejos de expertos sobre lo que hay que tener en cuenta para definir una estrategia de RCE s\u00f3lida.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Define_a_CER_protocol_and_strategy\"><\/span>1. Definir un protocolo y una estrategia de RCE<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Identificar los Requisitos Esenciales (Requisitos de Seguridad y Rendimiento en el MDR) que necesitan ser apoyados por la evidencia cl\u00ednica. Definir las m\u00e9tricas relativas al rendimiento, la seguridad y los puntos finales de riesgo\/beneficio.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Demonstrate_equivalence\"><\/span><strong>2. Demostrar la equivalencia<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>La equivalencia se determina a partir de la comparaci\u00f3n entre un producto sanitario y otros productos similares preexistentes con el marcado CE. La demostraci\u00f3n de la equivalencia se eval\u00faa en funci\u00f3n de par\u00e1metros relevantes definidos por el fabricante. La justificaci\u00f3n de la equivalencia debe explicarse completamente en la RCE. Los criterios de equivalencia se han vuelto complejos y estrictos, con mayores conexiones con los requisitos esenciales. Es fundamental evitar el error com\u00fan de seleccionar dispositivos equivalentes que no son relevantes para su producto. Se deben identificar y analizar los datos documentados para cada dispositivo equivalente y para las diferencias entre dispositivos.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Evaluate_literature_review_data\"><\/span><strong>3. Evaluar los datos de la revisi\u00f3n de la literatura<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"_04xlpA direction-ltr align-start para-style-body\">Si se puede demostrar adecuadamente la equivalencia, los datos cl\u00ednicos extra\u00eddos de la literatura sobre estudios anteriores son una herramienta valiosa para elaborar una RCE. Sin embargo, es fundamental que los estudios de la literatura se realicen en un proceso sistem\u00e1tico:<\/p>\n<p>- Prepare un protocolo completo para la revisi\u00f3n de la literatura,<br \/>\n- Definir las entradas y los par\u00e1metros, como las bases de datos, los t\u00e9rminos de b\u00fasqueda y los criterios de exclusi\u00f3n (idiomas, tipo\/dise\u00f1o del estudio, entorno del estudio, criterios de valoraci\u00f3n),<br \/>\n- Definir los criterios de seguridad y rendimiento necesarios en funci\u00f3n de los productos equivalentes y del an\u00e1lisis de riesgos,<br \/>\n- Reunir sistem\u00e1ticamente art\u00edculos relevantes de diferentes fuentes de datos,<br \/>\n- Analizar los datos utilizando un m\u00e9todo objetivo como un marco y utilizando m\u00faltiples revisores, y,<br \/>\n- Documentar las conclusiones de la evaluaci\u00f3n bibliogr\u00e1fica para incluirlas en el documento de la RCE.<\/p>\n<p><strong>Lea tambi\u00e9n: <a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">C\u00f3mo contratar a un redactor de informes de evaluaci\u00f3n cl\u00ednica para su producto sanitario<\/a>\u00a0<\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"4_Determine_requirement_for_clinical_investigation\"><\/span>4. Determinar los requisitos para la investigaci\u00f3n cl\u00ednica<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"_04xlpA direction-ltr align-start para-style-body\">La exigencia de una investigaci\u00f3n cl\u00ednica viene determinada por el perfil de riesgo del producto. Los productos de alto riesgo y de clase III deben ser objeto de una investigaci\u00f3n cl\u00ednica. La novedad tambi\u00e9n es un factor determinante, y los productos basados en tecnolog\u00edas innovadoras o para un nuevo uso previsto requieren una investigaci\u00f3n cl\u00ednica. Las pruebas cl\u00ednicas disponibles deben abordar todas las ER pertinentes. Esto puede garantizarse compartiendo el Plan de Investigaci\u00f3n Cl\u00ednica (PIC) con el organismo nacional correspondiente antes de su aplicaci\u00f3n.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_Monitor_post-market_activities\"><\/span>5. <strong>Supervisar las actividades posteriores a la comercializaci\u00f3n<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"_04xlpA direction-ltr align-start para-style-body\">De acuerdo con el MDR, las actividades del PMS deben estar adecuadamente planificadas y documentadas en el RCE. Tambi\u00e9n deben documentarse los procesos de evaluaci\u00f3n de los datos cl\u00ednicos en curso y de actualizaci\u00f3n de la RCE. Para garantizar que la RCE siga siendo pertinente durante todo el ciclo de vida del producto, debe actualizarse peri\u00f3dicamente mediante un proceso documentado. Esto incluye la evaluaci\u00f3n de los datos y la ponderaci\u00f3n de la relevancia de todos los dispositivos equivalentes.<\/p>\n<p><strong>\u00bfNecesita ayuda para redactar un informe de evaluaci\u00f3n cl\u00ednica? Contrate a un aut\u00f3nomo <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Escritor de CER para dispositivos m\u00e9dicos<\/a> en Kolabtree. Es gratis publicar tu proyecto y obtener presupuestos.<\/strong><\/p>\n<p>Expertos relacionados:<\/p>\n<p><strong><a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Consultores de dispositivos m\u00e9dicos<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Escritor m\u00e9dico aut\u00f3nomo<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Escritor aut\u00f3nomo de CER<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations--mdr-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Consultores de MDR de la UE<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Presentaciones a la FDA<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/services\/literature-search?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Expertos en b\u00fasqueda de bibliograf\u00eda<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-compliance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Expertos en cumplimiento normativo<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Experto en ensayos cl\u00ednicos<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Redactores de normativas<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/post-market-surveillance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Consultores de PMS<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/country\/india\/subject\/post-market-clinical-followup?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Consultores de PMCF<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u00a0Expertos en bioestad\u00edstica<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/product-development?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u00a0Experto en desarrollo de productos\u00a0<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Sophie Laurenson, innovadora en materia de salud y tecnolog\u00eda en Kolabtree, comparte 5 consejos para redactar un informe de evaluaci\u00f3n cl\u00ednica y definir una estrategia de RCE. El MDR de la UE ha tenido un impacto significativo en la forma en que se regulan los dispositivos m\u00e9dicos en Europa. Como parte del cumplimiento normativo, los fabricantes de productos sanitarios deben crear y mantener un informe de evaluaci\u00f3n cl\u00ednica (CER), un documento<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/es\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/\" title=\"Leer m\u00e1s\">Leer m\u00e1s<\/a><\/div>","protected":false},"author":12,"featured_media":6882,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[247,443,540],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Writing a Clinical Evaluation Report: 5 Quick Tips - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"Quick tips on writing a clinical evaluation report (CER) for medical device compliance with the EU MDR.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/es\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Writing a Clinical Evaluation Report: 5 Quick Tips\" \/>\n<meta property=\"og:description\" content=\"Quick tips on writing a clinical evaluation report (CER) for medical device compliance with the EU MDR.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/es\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2020-02-07T13:14:07+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-04-06T12:36:40+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/02\/writing-a-clinical-evaluation-report.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1280\" \/>\n\t<meta property=\"og:image:height\" content=\"853\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ramya Sriram\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutos\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Writing a Clinical Evaluation Report: 5 Quick Tips - 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